Effect of Sedation Strategy on Duration Mechanical Ventilation in Patient After Cardiac Surgery

Respiratory Failure Clinical Trial

Official title:

Comparing Effect of Propofol, Dexmedetomidine and Their Combination on Duration Mechanical Ventilation in Patient After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451121
• Other study ID #: 0120U100656
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2022
• Source: Anesthesia Research Group UA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a direct relationship between the sedative agent and the duration of ventilation.

Description:

Sedation and sedative agent have direct correlation to the mechanical length. As known mechanical length could increase length of the hospital stay (LOHS) and mortality rate. The right sedative agent can decrease the length go the mechanical ventilation. The goal of the research to compare 3 sedation strategies and their influence to the duration of mechanical ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Multi vascular lesions of the coronary arteries according to coronary angiography;
• Heart valve damage was confirmed by, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
• Age of patients from 18-80 years; • Patient consent to participate in the study;

Exclusion Criteria:

• Refusal to participate;
• Hypersensitivity to propofol, dexmedetomidine;
• Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
• Occurred ischemic stroke;
• History of the ischemic stroke;
• History of the neurodegenerative diseases;
• History of the mental disorders;
• Use of neuroleptics, antidepressants for the last 5 years;
• History of the cardiac surgery in the past;
• Patients with chronic pulmonary disease (GOLD 3-4)
• Patients with asthma (moderate or severe),
• Participation in any other clinical trial;
• Chronic renal failure (ClCr less than 50 ml / h)
• Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
• Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR> 1.5)
• If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery),
• History of the hematological disease;
• Alcohol abuse in the anamnesis (3-4 times a week).
• Condition after chemotherapy;
• Pregnancy, lactation.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Respiratory Failure
• Respiratory Insufficiency
• Sedation Complication

Intervention

Drug:
• Propofol
patient sedation with a propofol (sedative agent) after cardiac surgery
• Dexmedetomidine
patient sedation with dexmedetomidine (selective a2-adrenergic receptor (a2-AR) agonist) after cardiac surgery
• Propofol and dexmedetomidine
Patients sedation with a drug combination: propofol and dexmedetomidine (selective a2-adrenergic receptor (a2-AR) agonist)

Locations

Country	Name	City	State
Ukraine	Anesthesia department Medical Network Dobrobut	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Anesthesia Research Group UA

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of the mechanical ventilation	measure the length of the mechanical ventilation	after cardiac surgery till extubation (up to first 24 hour after surgery)
Secondary	Length of the ICU stay	th? amount of the days spent in the ICU	at the day of discharge of ICU (assessed up to day 5)
Secondary	Length of the hospital stay	th? amount of the days spent in the hospital	at the day of discharge of hospital (assessed up to day 5)